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About the Role

The Contractor, Clinical Trial Associate will support the conduct of clinical trials by managing certain aspects, partnering with Clinical Project Managers and Clinical Trial Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.

Responsibilities

• Maintain the Trial Master Files (TMF), including receipt, review, QC, tracking, and filing of all documents per Syndax SOPs.
• Ensure TMF is inspection ready.
• Provide TMF metrics to internal and external stakeholders.
• Work closely with cross-functional teams to adhere to the trial master oversight plan.
• Assist with the development and maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits, and site payments.
• Assist in the oversight of CROs to ensure the successful conduct of clinical trials.
• Attend and participate in Clinical Trial Working Groups as needed.
• Assist in reviewing monitoring visit reports.
• Review site-specific Informed Consent Forms.
• Track site feasibility questionnaires.
• Assist in the planning of various meetings and events for the Clinical Operations Team.
• Reconcile invoices to contracts and budget, and assist with investigator site payments.
• Prepare and manage study communications, including newsletters and study updates.
• Record, prepare, and distribute meeting minutes for assigned clinical trials.
• Assist with the preparation of all external and internal documentation for assigned trials to ensure GCP regulatory compliance and consistency with the study protocol.

Requirements

• Two years’ experience in Veeva Vault.
• Two or more years’ experience in clinical operations, with experience in both a CRO and Sponsor setting desired.
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
• Demonstrated efficiency in partnering with CROs and vendors.
• Computer proficiency in Veeva TMF, Word, Excel, PowerPoint, and Smart Sheet.
• Ability to work proactively and efficiently in a fast-paced, high-change environment.
• Excellent written and oral communication skills.
• Outstanding organization skills.

Skills

• Veeva Vault
• Veeva TMF
• Word
• Excel
• PowerPoint
• Smart Sheet
• Clinical Operations
• CRO and Sponsor setting experience
• FDA regulatory requirements
• ICH/GCP guidelines
• Partnering with CROs and vendors
• Communication skills
• Organization skills

Location

• New York City
• Remote (preference for east coast locations)

Work Type

• Contract
• Remote

Experience Level

• Two years’ experience in Veeva Vault
• Two or more years’ experience in clinical operations

Education Level

• Bachelor's degree desired, preferably in a science or healthcare related discipline

About the Company

• Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies.
• The company's pipeline includes a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease.
• Syndax is committed to reimagining cancer care and is conducting several clinical trials across the continuum of treatment.
• For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Equal Opportunity

• Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.